Conventionally, shielding light of a specific wavelength has often been suggested as a function of enhancing storage stability of contents in sheets, packages, and containers for storing pharmaceutical products, medical supplies, various cosmetics, foods and the like as contents.
Sheets and containers that prevent deterioration in quality of contents by the influence of deterioration due to ultraviolet rays and the like are demanded for some of pharmaceutical products and medical supplies such as medicines, various cosmetics, foods, and the like, which are stored in PTP packaging and blister packaging, obtained by thermoforming a blister sheet, a soft bag such as an infusion solution and liquid medicine bag, a plastic ampoule and vial, and a syringe.
Containers for infusion solutions and liquid medicines are used for various infusion solutions and pharmaceutical products. However, when drugs which are easily deteriorated by light, particularly, vitamins and amines are contained in various infusion solutions and pharmaceutical products, it is necessary to protect the contents from light and to shield light not only in an ultraviolet range but also in a visible range from these drugs.
These infusion solutions and liquid medicines are prepared in advance or prepared when being used (dripped). Since these infusion solutions and liquid medicines are generally stored in a packing material having light-shielding properties such as cardboard until being used, there is substantially no possibility that these solutions and liquid medicines are exposed to light and a main problem is deterioration due to light while being used. Therefore, when these solutions and medicines are used, a container such as an infusion solution bag is covered with a cover made of a light-shielding film in many cases. However, since the light-shielding film is colored, it is difficult to visually check the state of the infusion solution in the infusion solution container and changes in the liquid level and the dripping progress state cannot be grasped. Thus, there is a possibility that appropriate dripping cannot be achieved.
In order to solve such a problem, Japanese Publication No. 2003-275280 discloses a light-shielding cover for an infusion solution container that is covered an infusion solution bag with a colored film later for realizing light-shielding and provided with a window for checking the amount of contents remaining However, with this configuration, an infusion solution bag which is an immediate container does not have any light-shielding function and there is a concern of deterioration in quality of contents such as drugs which are sensitive to light due to light such as ultraviolet rays in a step of drug filling or in a step of inspection.
Japanese Publication No. 2008-230112 discloses a laminated body that is used for PTP packaging or blister packing. A laminating material for pharmaceutical products and medical supplies is a laminating material which has a function of shielding light of a specific wavelength (light shielding properties) and oxygen barrier properties and an ultraviolet absorber and a yellow pigment are kneaded in the laminating material. Application of ink imparts a function of shielding light of a specific wavelength and an oxygen barrier function. However, countermeasures for inhibiting substances from being eluted from the ultraviolet absorber, yellow pigment and ink, which are used for imparting a light-shielding function, into the contents are not taken.
In addition, the total light transmittance at a wavelength of 500 nm is 5% or lower, and the visibility of the contents is not good. For example, in the testing method for pharmaceutical containers described in the Japanese Pharmacopoeia, regarding the transparency of containers, the total light transmittance at a wavelength of 450 nm is 55% or more. It is relatively easy to shield light with a wavelength of 500 nm or less. However, it is not easy to achieve a total light transmittance at a wavelength of 450 nm of 55% or more while shielding light in an ultraviolet range with a wavelength of 400 nm or less.
Japanese Publication No. 2007-302328 discloses a light-shielding laminated sheet as an outer packaging bag for a prefilled syringe. As described above, there are many examples of outer packaging bags in which a light-shielding function is not imparted to an immediate container that comes into contact with a pharmaceutical product and these outer packaging bags are preferable from the viewpoint of safety of contents. However, with the same configuration as in the Japanese Publication No. 2003-275280, a prefilled syringe which is an immediate container does not have any light-shielding function and there is a concern of deterioration in quality of contents such as drugs, which are sensitive to light, due to light such as ultraviolet rays in a step of drug filling or in a step of inspection.
On the other hand, Japanese Publication No. H8-193149 discloses a container obtained using a coloring pigment in an infusion solution bag itself as a container in which a light-shielding function is provided to an immediate container that comes into contact with the contents. Among these, an infusion solution bag is strictly restricted by the testing method for plastic containers for infusion solutions described in the Japanese Pharmacopoeia of Pharmaceutical Affairs Law. For example, a general organic absorbent cannot be used in an eluate test. Further, there are difficulties that the ignition residue is limited to 0.10% or less and an inorganic ultraviolet absorber such as titanium dioxide particulates cannot be used. Therefore, there is disclosed a colored resin composition for an infusion solution bag which did not exist in the past and has excellent physiological safety, a high degree of transparency, heat resistance, and an ultraviolet absorbing effect over almost the entire ultraviolet range in a pigment composition investigation without causing elution. This resin composition can be suitably used for an infusion solution bag and a packaging material thereof.
However, the composition almost completely shields the light of a wavelength of 450 nm and the content visibility is not good. As described above, in the testing method for pharmaceutical containers described in the Japanese Pharmacopoeia, regarding the transparency of containers, the total light transmittance at a wavelength of 450 nm is 55% or more. It is relatively easy to shield light of 500 nm or less as in Japanese Publication No. H8-193149. However, it is not easy to achieve a total light transmittance at a wavelength of 450 nm of 55% or more while shielding light in an ultraviolet range of 400 nm or less.
As a container in which a light-shielding function is provided to an immediate container for storing a pharmaceutical product, Japanese Publication No. 2008-104868 discloses a plastic ampoule. From the viewpoint of preventing elution of a pigment and an ultraviolet absorber into a drug, cyclic olefin having a glass transition temperature of 60° C. to 80° C. is used for an intermediate layer of the container. However, since the pigment and the ultraviolet absorber are added to the outer layer of the cyclic olefin layer and in such a container, the pigment and the ultraviolet absorber are bled out of the container. Thus, there is a possibility of causing contamination of the container or other products. In addition, at a glass transition temperature of 60° C. to 80° C., for use in a high temperature region, intermolecular motion is promoted and elution of the components into the liquid contents cannot be inhibited. Therefore, these problems are not completely solved.